a study comparing the effectiveness and safety of ultracet® (tramadol hcl/acetaminophen) versus placebo for the treatment of acute pain from a migraine headache

Conditions: Migraine; Head Pain; Headache

Summary: the purpose of this study is to evaluate the effectiveness and safety of tramadol hcl/acetaminophen as a pain medication compared with placebo in the treatment of acute pain from a migraine headache. although tramadol hcl/acetaminophen is approved to treat acute pain, it is not approved for the treatment of acute pain associated with migraine headache. the study hypothesis is that tramadol hcl/acetaminophen is safe and effective as a pain medication in the treatment of acute pain associated with a migraine headache.

although new drugs and procedures are available to treat acute migraine pain, inadequacies in treatment still exist. the ingredients in tramadol hcl/acetaminophen tablet and the way it works may be effective in the treatment of the pain of acute migraine headache. the combination of tramadol hcl/ acetaminophen works faster than tramadol alone and lasts longer than acetaminophen alone. this is a multicenter, single-dose, outpatient, randomized (study with two groups one in treatment and one control group), double-blind (neither patient nor investigator knows which patient is receiving study drug or control treatment), placebo-controlled, parallel-group (each group receives only one type of treatment) study of adult patients who experience at least moderate pain from migraine headaches. after being randomly assigned to a group patients will leave the study center with one dose (2 tablets) of study medication, either active treatment or placebo. the next time the patient has a migraine headache of at least moderate pain, the patient will take the study medication and start to answer questions about their headache pain and pain relief in a study diary. patients should return to the study center within 72 hours of taking this dose. the study hypothesis is that tramadol hcl/acetaminophen is safe and effective as a pain medication in the treatment of acute pain associated with a migraine headache. 2 tramadol hcl (37.5 milligrams)/acetaminophen (325 milligrams) combination tablets or 2 matching placebo (inactive substance) tablets for tramadol hcl/acetaminophen taken one time orally

Eligibility criteria:
inclusion criteria: * patient with a history of diagnosis of migraine with or without a warning sign (aura), that meets the criteria for a migraine, for at least 1 year * history of migraine pain at least moderate in intensity * incidence of 1 to 6 headaches per month in the past year * if female, using acceptable method of birth control exclusion criteria: * patients with routine headaches that could be confused with migraines * no more than 13 headache days per month in the past 6 months * onset of migraines after age 50 * patients with migraines involving the eyes, chronic migraine or cluster headaches * patients using one or more of the following medications before study entry: more than 1 type of migraine prevention medicine in the past 6 weeks, tramadol within 30 days, vitamins/herbal remedies or non-drug-related remedies for migraine for \< 30 days, st. john's wort within 30 days, investigational drug in past 30 days or any other disallowed medications

Keywords: treatment pain acute migraine headache